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View ICR - OIRA Conclusion

OMB Control No: 0910-0862	ICR Reference No: 201810-0910-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Labeling of Red Blood Cell Units with Historical Antigen Typing Results
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/26/2018
	Date Received in OIRA: 10/23/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	36 Months From Approved
Responses	1	0	0
Time Burden (Hours)	1	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	1	1
Annual Time Burden (Hours)	1	1
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Agency guidance being issued that discusses implementation of labeling provisions for certain blood/biologics under existing FDA regulations.

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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